Abbreviated New Drug Application Software

Elevate Efficiency and Compliance in Lifesciences

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ANDA Management Made Simple

AmpleLogic’s ANDA (Abbreviated New Drug Application) software is a comprehensive solution designed to streamline the management of regulatory submissions and interactions for pharmaceutical and biotech organizations seeking approval for generic drug products. It offers features such as comprehensive tracking, automated reminders, centralized access to information, data integration from various sources, and access control for enhanced security.

This solution ensures enhanced compliance, streamlined operations, timely responses to regulatory inquiries, improved efficiency in managing submissions, and confidence in meeting regulatory standards.

Elevate Regulatory Excellence: Features & Benefits

Comprehensive-Tracking

Comprehensive Tracking

Monitor all aspects of regulatory submissions and interactions.

Automated-Reminders

Automated Reminders

Receive timely notifications for regulatory deadlines and commitments.

Centralized-Access

Centralized Access

Access all relevant information in one centralized platform.

Data-Integration

Data Integration

Seamlessly integrate data from various sources for enhanced oversight.

Access-Control-01

Access Control

Ensure secure access with role-based restrictions for data integrity.

Empowering Your Regulatory Journey

Ensure adherence to regulatory requirements and deadlines.

Optimize regulatory processes for efficiency and productivity.

Promptly address regulatory inquiries and requirements.

Increase efficiency in managing ANDA submissions and interactions.

Gain assurance in regulatory compliance and management.

Hear From Our Customers

Paramita-Sarkar
Paramita Sarkar Vice President, OCuSOFT

AmpleLogic understood the limitations we had as a growing organization. With the budget constraints we had, we couldn’t have been able to find a better, flexible and customizable partner than AmpleLogic. We appreciate the team.
Om-Prakash-Sule
OM Prakash Sule Vice President, Windlas

Windlas Biotech is committed for transparent Quality Management System and other records. "This is the reason we opted for part 11 compliant partner AmpleLogic. Great contribution by AmpleLogic team to make it Live in shortest possible time"
Georges-Ibrahim
Georges Ibrahim CQO, Julphar

AmpleLogic’s QMS application has higher level of transparency and efficacy. It has helped us in tracking day to day quality processes to manage huge information and data and also have transparency in managing
complaints.

Frequently Asked Questions

ANDA stands for Abbreviated New Drug Application, crucial for obtaining approval for generic drug products, ensuring affordability and accessibility.

It centralizes tracking, automates reminders, and ensures compliance, facilitating efficient management of submissions and interactions.

Yes, it seamlessly integrates data from various sources like change controls and adverse event reports, enhancing regulatory oversight.

Access restrictions based on job responsibilities ensure regulatory users have appropriate access, maintaining data integrity and confidentiality.

Enhanced compliance, streamlined operations, timely responses, improved efficiency, and increased confidence in regulatory processes are among the key benefits.

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Your Pharma Automation Starts Here

We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:

Your benefits:
  • Client-oriented
  • Independent
  • Competent
  • Results-driven
  • Problem-solving
  • Transparent
What happens next?
1

We Schedule a call at your convenience 

2

We do a discovery and consulting meeting 

3

We prepare a proposal 

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